Does gabapentin provide benefit for patients with knee OA? A benefit-harm and cost-effectiveness analysis.

OBJECTIVE: Gabapentin can treat neuropathic pain syndromes and has increasingly been prescribed to treat nociplastic pain. Some patients with knee osteoarthritis (OA) suffer from both nociceptive and nociplastic pain. We examined the cost-effectiveness of adding gabapentin to knee OA care. METHOD: We used the Osteoarthritis Policy Model, a validated Monte Carlo simulation of knee OA, to examine the value of gabapentin in treating knee OA by comparing three strategies: 1) usual care, gabapentin sparing (UC-GS); 2) targeted gabapentin (TG), which provides gabapentin plus usual care for those who screen positive for nociplastic pain on the modified PainDETECT questionnaire (mPD-Q) and usual care only for those who screen negative; and 3) universal gabapentin plus usual care (UG). Outcomes included cumulative quality-adjusted life years (QALYs), lifetime direct medical costs, and incremental cost-effectiveness ratios (ICERs), discounted at 3% annually. We derived model inputs from published literature and national databases and varied key input parameters in sensitivity analyses. RESULTS: UC-GS dominated both gabapentin-containing strategies, as it led to lower costs and more QALYs. TG resulted in a cost increase of $689 and a cumulative QALY reduction of 0.012 QALYs. UG resulted in a further $1,868 cost increase and 0.036 QALY decrease. The results were robust to plausible changes in input parameters. The lowest TG strategy ICER of $53,000/QALY was reported when mPD-Q specificity was increased to 100% and AE rate was reduced to 0%. CONCLUSION: Incorporating gabapentin into care for patients with knee OA does not appear to offer good value.

A systematic review: impact of in-office biopsy on safety and waiting times in head and neck cancer.

OBJECTIVE: This study aimed to assess the current literature on the safety and impact of in-office biopsy on cancer waiting times as well as review evidence regarding cost-efficacy and patient satisfaction. METHOD: A search of Cinahl, Cochrane Library, Embase, Medline, Prospero, PubMed and Web of Science was conducted for papers relevant to this study. Included articles were quality assessed and critically appraised. RESULTS: Of 19 741 identified studies, 22 articles were included. Lower costs were consistently reported for in-office biopsy compared with operating room biopsy. Four complications requiring intervention were documented. In-office biopsy is highly tolerated, with a procedure abandonment rate of less than 1 per cent. When compared with operating room biopsy, it is associated with significantly reduced time-to-diagnosis and time-to-treatment initiation. It is linked to improved overall three-year survival. CONCLUSION: In-office biopsy is a safe procedure that may help certain patients avoid general anaesthetic. It was shown to significantly reduce time-to-diagnosis and time-to-treatment initiation when compared with operating room biopsy. This may have important implications for oncological outcomes. In-office biopsy requires fewer resources and is likely to be cost-saving five-years following introduction. With high rates of sensitivity and specificity, in-office biopsy should be considered as the first-line procedure to achieve tissue diagnosis.

An economic evaluation of the randomized controlled trial of topical corticosteroid and home-based narrowband ultraviolet B for active and limited vitiligo (the HI-Light Vitiligo Trial).

BACKGROUND: Economic evidence for vitiligo treatments is absent. OBJECTIVES: To determine the cost-effectiveness of (i) handheld narrowband ultraviolet B (NB-UVB) and (ii) a combination of topical corticosteroid (TCS) and NB-UVB compared with TCS alone for localized vitiligo. METHODS: Cost-effectiveness analysis alongside a pragmatic, three-arm, placebo-controlled randomized controlled trial with 9 months' treatment. In total 517 adults and children (aged ≥ 5 years) with active vitiligo affecting < 10% of skin were recruited from secondary care and the community and were randomized 1: 1: 1 to receive TCS, NB-UVB or both. Cost per successful treatment (measured on the Vitiligo Noticeability Scale) was estimated. Secondary cost-utility analyses measured quality-adjusted life-years using the EuroQol 5 Dimensions 5 Levels for those aged ≥ 11 years and the Child Health Utility 9D for those aged 5 to < 18 years. The trial was registered with number ISRCTN17160087 on 8 January 2015. RESULTS: The mean ± SD cost per participant was £775 ± 83·7 for NB-UVB, £813 ± 111.4 for combination treatment and £600 ± 96·2 for TCS. In analyses adjusted for age and target patch location, the incremental difference in cost for combination treatment compared with TCS was £211 (95% confidence interval 188-235), corresponding to a risk difference of 10·9% (number needed to treat = 9). The incremental cost was £1932 per successful treatment. The incremental difference in cost for NB-UVB compared with TCS was £173 (95% confidence interval 151-196), with a risk difference of 5·2% (number needed to treat = 19). The incremental cost was £3336 per successful treatment. CONCLUSIONS: Combination treatment, compared with TCS alone, has a lower incremental cost per additional successful treatment than NB-UVB only. Combination treatment would be considered cost-effective if decision makers are willing to pay £1932 per additional treatment success.

Repeatability of plantar pressure assessment during barefoot walking in people with stroke.

PURPOSE: Stroke-related changes in foot structure and function affect balance and mobility and quantifying foot function following stroke could offer clinically useful information to inform rehabilitation. The aim of this work was to explore the feasibility of undertaking plantar pressure assessment during barefoot walking in people with stroke, and evaluate the repeatability of the assessment protocol and regional footprint analysis as a measure of dynamic foot characteristics. MATERIALS & METHODS: Plantar pressure analysis was undertaken using a pressure platform (Tekscan HR Mat) on two test sessions, approximately two weeks apart (mean = 15.64 ± 11.64 days). Peak plantar pressure (kPa) and contact area (cm2) for foot regions were extracted and repeatability analysis undertaken. Descriptive evaluation of field notes and experiences of the participants was undertaken to inform the feasibility of the data collection protocol. RESULTS: Twenty-one participants (61.8 ± 9.2 years; 11 male, 10 female; 8 right-sided, 13 left-sided stroke) were recruited and 18 returned for retesting. Full data capture was achieved from 14 participants. Peak pressure and contact area demonstrated moderate to good repeatability for at the toes (ICC 0.76 and 0.58 respectively) and good to excellent repeatability for the other foot regions (ICC ≥ 0.82). CONCLUSION: The protocol adopted in this study was feasible and yielded good to excellent repeatability for the foot regions, except the toes. The challenges with data collection in our study cohort could help inform future studies adopting similar protocols. This work also has relevance for use of pressure technology in clinical practice for assessing and monitoring foot function following stroke.

Antarctic Futures: An Assessment of Climate-Driven Changes in Ecosystem Structure, Function, and Service Provisioning in the Southern Ocean.

In this article, we analyze the impacts of climate change on Antarctic marine ecosystems. Observations demonstrate large-scale changes in the physical variables and circulation of the Southern Ocean driven by warming, stratospheric ozone depletion, and a positive Southern Annular Mode. Alterations in the physical environment are driving change through all levels of Antarctic marine food webs, which differ regionally. The distributions of key species, such as Antarctic krill, are also changing. Differential responses among predators reflect differences in species ecology. The impacts of climate change on Antarctic biodiversity will likely vary for different communities and depend on species range. Coastal communities and those of sub-Antarctic islands, especially range-restricted endemic communities, will likely suffer the greatest negative consequences of climate change. Simultaneously, ecosystem services in the Southern Ocean will likely increase. Such decoupling of ecosystem services and endemic species will require consideration in the management of human activities such as fishing in Antarctic marine ecosystems.

Correction: Cost and time-effective method for multi-scale measures of rugosity, fractal dimension, and vector dispersion from coral reef 3D models.

[This corrects the article DOI: 10.1371/journal.pone.0175341.].

A multicentre, clinical evaluation of a hydro-responsive wound dressing: the Glasgow experience.

OBJECTIVE: Our aim was to assess the effectiveness of hydro-responsive wound dressing (HRWD) in debridement and wound bed preparation of a variety of acute and chronic wounds that presented with devitalised tissue needing removal so that healing may proceed. METHOD: This was a non-comparative evaluation of acute and chronic wounds that required debridement as part of their normal treatment regimen. Clinicians recorded wound changes including a subjective assessment level of devitalised tissue and wound bed preparation, presence of pain, wound status (e.g., wound size) and periwound skin condition. Data was also collected from clinicians and patients to provide information on clinical performance of the dressing. RESULTS: We recruited 100 patients with a variety of wound types into the study. Over 90% of the clinicians reported removal of devitalised tissue to enable a healing response in both chronic and acute wounds. Specifically, over the course of the evaluation period, levels of devitalised tissue (necrosis and slough) reduced from 85.5% to 26.3%, and this was accompanied by an increase in wound bed granulation from 12.0% to 33.7%. Correspondingly, there was a 40% reduction in wound area, hence a clinically relevant healing response was seen upon treatment with HRWD. It is also noteworthy that this patient population included a significant proportion of chronic wounds (51.4%) that showed no signs of wound progression within <4 weeks before study inclusion. Of these chronic wounds, 93% demonstrated wound progression upon treatment with HRWD. Despite reported pain levels being low pre- and post-dressing change, overall wound pain improved (reduced) in 48% of patients. Periwound skin condition showed a tendency towards improvement, and the fluid management capabilities of the HRWD was reported as good to excellent in the majority of cases. Wound infections were reduced by at least 60% over the evaluation period. A simple cost-effective analysis demonstrated significant savings using HRWD (£6.33) over current standard practice regimens of a four-step debridement process (£8.05), larval therapy (£306.39) and mechanical pad debridement (£11.46). CONCLUSION: HRWD was well tolerated and was demonstrated to be an efficient debridement tool providing rapid, effective and pain free debridement in a variety of wound types.

Cost and time-effective method for multi-scale measures of rugosity, fractal dimension, and vector dispersion from coral reef 3D models.

We present a method to construct and analyse 3D models of underwater scenes using a single cost-effective camera on a standard laptop with (a) free or low-cost software, (b) no computer programming ability, and (c) minimal man hours for both filming and analysis. This study focuses on four key structural complexity metrics: point-to-point distances, linear rugosity (R), fractal dimension (D), and vector dispersion (1/k). We present the first assessment of accuracy and precision of structure-from-motion (SfM) 3D models from an uncalibrated GoPro™ camera at a small scale (4 m2) and show that they can provide meaningful, ecologically relevant results. Models had root mean square errors of 1.48 cm in X-Y and 1.35 in Z, and accuracies of 86.8% (R), 99.6% (D at scales 30-60 cm), 93.6% (D at scales 1-5 cm), and 86.9 (1/k). Values of R were compared to in-situ chain-and-tape measurements, while values of D and 1/k were compared with ground truths from 3D printed objects modelled underwater. All metrics varied less than 3% between independently rendered models. We thereby improve and rigorously validate a tool for ecologists to non-invasively quantify coral reef structural complexity with a variety of multi-scale metrics.

The hospital costs associated with acute paediatric burn injuries.

BACKGROUND: Ongoing rationing of healthcare threatens services that are well established, and cripples others that desperately require investment. Burn, for one, remains a neglected epidemic in South Africa (SA), despite the magnitude of the problem. OBJECTIVE: To identify the prominent components contributing to the cost of hospital admission with paediatric burn injury. Determining the true costs of specialist services is important, so that resources can be allocated appropriately to achieve the greatest possible impact. METHODS: A retrospective study was undertaken over 1 year to determine patient demographics and injury details of 987 patients admitted with burn injuries to Red Cross War Memorial Children's Hospital, Cape Town, SA. The in-hospital financial records of 80 randomly selected patients were examined. This was followed by a prospective study to determine the financial implications of four cost drivers, i.e. bed cost per day, costs of medications received, costs of dressings for wound care, and costs of surgical intervention. A random selection of 37 dressing changes (in 31 paediatric patients) and 19 surgical interventions was observed, during which all costs were recorded. RESULTS: As expected, severe flame burns are responsible for more prolonged hospital stays and usually require surgical intervention. Scald burns comprise the greatest proportion of burn injuries, and therefore account for a considerable part of the hospital's expenditure towards burn care. CONCLUSION: While community programmes aiming to prevent burn injuries are important, this study motivates for the implementation of accessible ambulatory services in low-income areas. This strategy would enable the burn unit to reduce its costs by limiting unnecessary admissions, and prioritising its resources for those with more severe burn injuries.

Developing the radiation protection safety culture in the UK.

In the UK, as elsewhere, there is potential to improve how radiological challenges are addressed through improvement in, or development of, a strong radiation protection (RP) safety culture. In preliminary work in the UK, two areas have been identified as having a strong influence on UK society: the healthcare and nuclear industry sectors. Each has specific challenges, but with many overlapping common factors. Other sectors will benefit from further consideration.In order to make meaningful comparisons between these two principal sectors, this paper is primarily concerned with cultural aspects of RP in the working environment and occupational exposures rather than patient doses.The healthcare sector delivers a large collective dose to patients each year, particularly for diagnostic purposes, which continues to increase. Although patient dose is not the focus, it must be recognised that collective patient dose is inevitably linked to collective occupational exposure, especially in interventional procedures.The nuclear industry faces major challenges as work moves from operations to decommissioning on many sites. This involves restarting work in the plants responsible for the much higher radiation doses of the 1960/70s, but also performing tasks that are considerably more difficult and hazardous than those original performed in these plants.Factors which influence RP safety culture in the workplace are examined, and proposals are considered for a series of actions that may lead to an improvement in RP culture with an associated reduction in dose in many work areas. These actions include methods to improve knowledge and awareness of radiation safety, plus ways to influence management and colleagues in the workplace. The exchange of knowledge about safety culture between the nuclear industry and medical areas may act to develop RP culture in both sectors, and have a wider impact in other sectors where exposures to ionising radiations can occur.

The dilemma of treating major burns in South Africa.

The major challenge facing South African burn surgeons is the current and future management of major burns. Survival is greatly dependent on adequate therapeutic measures. Various therapeutic measures can be instituted to overcome the shortage of donor skin, as we describe. Each of these methods has its specific role in the management of major burns. The use of very expensive and highly specialised techniques for individual patients cannot be justified when more accessible and cost-effective methods are available. To serve the greater population of burn victims, every effort should be made to use these available methods rather than channelling scarce financial resources into procedures that have a very limited role in South Africa. 

A safety assessment of branched chain saturated alcohols when used as fragrance ingredients.

The Branched Chain Saturated Alcohol (BCSA) group of fragrance ingredients was evaluated for safety. In humans, no evidence of skin irritation was found at concentrations of 2-10%. Undiluted, 11 materials evaluated caused moderate to severe eye irritation. As current end product use levels are between 0.001% and 1.7%, eye irritation is not a concern. The materials have no or low sensitizing potential. For individuals who are already sensitized, an elicitation reaction is possible. Due to lack of UVA/UVB light-absorbing structures, and review of phototoxic/photoallergy data, the BCSA are not expected to elicit phototoxicity or photoallergy. The 15 materials tested have a low order of acute toxicity. Following repeated application, seven BCSA tested were of low systemic toxicity. Studies performed on eight BCSA and three metabolites show no in vivo or in vitro genotoxicity. A valid carcinogenicity study showed that 2-ethyl-1-hexanol is a weak inducer of liver tumors in female mice, however, the relevance of this effect and mode of action to humans is still a matter of debate. The Panel is of the opinion that there are no safety concerns regarding BCSA under the present levels of use and exposure.

Counting the cost of complementary and alternative therapies in an Irish neurological clinic.

BACKGROUND AND PURPOSE: Complementary and alternative therapy (CAT) use is frequent in patients with the common neurological disorders despite little scientific evidence of its efficacy. Little is known about the cost of regular CAT use. The purposes of this study were to determine the frequency and cost of CAT use in patients attending a neurology out-patient clinic and to determine whether neurological diagnosis affects CAT use. METHODS: All patients attending the neurology out-patient clinic were asked to complete a structured questionnaire which included demographic information, details on the underlying neurological diagnosis, use and cost of CAT. RESULTS: Six hundred and seventy-one patients completed the questionnaire. Over 60% of the patients had used CAT, and 25% used CAT on a regular basis. Only 25% of patients using CAT had informed their doctor. Rates of CAT use varied with neurological diagnosis. Of those using CAM on a regular basis, the mean annual cost was Euro 1351. CONCLUSION: Patients attending our neurology out-patient department use CAT frequently and often do not inform their doctor. Patients spend a significant amount of personal income on CAT. Given the implications, including potential interactions with prescribed medication, these findings should prompt doctors to ask every patient about CAT use.

A toxicologic and dermatologic assessment of cyclic acetates when used as fragrance ingredients.

An evaluation and review of a structurally related group of fragrance materials.

Costs, benefits and the evolution of inducible defences: a case study with Daphnia pulex.

Phenotypic plasticity is one major source of variation in natural populations. Inducible defences, which can be considered threshold traits, are a form of plasticity that generates ecological and evolutionary consequences. A simple cost-benefit model underpins the maintenance and evolution of these threshold, inducible traits. In this model, a rank-order switch in expected fitness, defined by costs and benefits of induction between defended and undefended morphs, predicts the risk level at which individuals should induce defences. Here, taking predator-induced morphological defences in Daphnia pulex as a threshold trait, we provide the first comprehensive investigation into the costs and benefits of a threshold trait, and how they combine to reflect fitness and predict the switchpoint at which induction should occur. We develop reaction norms that show genetic variation in switchpoints. Further experiments show that induction can confer a survival benefit and a cost in terms of lifetime reproductive success. Together, these two traits combine to estimate expected fitness and can predict the switchpoint between an undefended and a defended strategy. The predictions match the reaction norm data for clones that experience these costs and benefits, and correspond well to independent field data on induction. However, predictions do not, and cannot, match for clones that do not gain a benefit from induction. This study confirms that a simple theory, based on life history costs and benefits, is a sufficient framework for understanding the ecology and evolution of inducible, threshold traits.

Cost effectiveness of the Expert Patients Programme (EPP) for patients with chronic conditions.

OBJECTIVE: To assess the cost effectiveness of the Expert Patients Programme (EPP) intervention compared to a treatment as usual alternative. DESIGN: Two-arm pragmatic randomised controlled trial design with waiting list control. SETTING: Community settings in England. PATIENTS: Patients with a wide range of self-defined long-term conditions. INTERVENTION: The EPP based on the US chronic disease self management program (CDSMP), a lay-led self-care group involving six weekly sessions to teach self-care support skills. MAIN OUTCOME MEASURES: Costs estimated over a 6-month period from a societal perspective. Health outcomes estimated in terms of quality adjusted life years (QALYs) generated by patients' response to the EQ5D at baseline and 6-month follow-up. RESULTS: The intervention group is associated with better patient outcomes, at slightly lower cost. Specifically, the intervention group has a 0.020 QALY gain compared with the control group, and a reduced cost of around 27 pounds per patient. The intervention would therefore be considered dominant. While the QALYs gained are small in absolute terms, an additional 0.02 QALY is equivalent to an extra one week of perfect health per year. When the value of a QALY is 20,000 pounds the EPP has a probability of 94% of being cost effective. Indeed, for all plausible values of willingness-to-pay for a QALY the EPP group is more likely to be cost effective than the control group. CONCLUSIONS: The EPP intervention evaluated in this trial is very likely to provide a cost effective alternative to usual care in people with long-term conditions.

A toxicologic and dermatologic assessment of related esters and alcohols of cinnamic acid and cinnamyl alcohol when used as fragrance ingredients.

An evaluation and review of a structurally related group of fragrance materials.